Packaging and process for the sterile packaging of objects for medical, pharmaceutical or cosmetic applications

ABSTRACT

Packaging for the sterile storage and transport of objects for medical, pharmaceutical or cosmetic applications and a packaging process are provided. The packaging includes at least one bag made of a first and a second web, bonded to one another, a feature thereof being that the first web consists of a selectively permeable nonwoven fabric and that the second web consists of a laminated film with at least three layers, where the first layer is a polymer film arranged on the external side of the bag, the second layer is a lamination adhesive and the third layer is a polymer film arranged on the internal side of the bag. At least one of the layers of the second web includes one or more pigments. In an 8-bit greyscale image, the seal seam, imaged in transmitted light and contrast-standardized, is depicted within a greyscale value range of 50-200.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims benefit under 35 USC § 119 of EuropeanApplication 19183002.5 filed Jun. 27, 2019, the entire contents of whichare incorporated herein by reference.

BACKGROUND 1. Field of the Invention

The present invention relates to packaging for the sterile storage andtransport of objects for medical, pharmaceutical or cosmeticapplications, in particular of sterile primary pharmaceutical packagingmeans, for example vials, ampoules, syringes or carpules, and apackaging process.

2. Description of Related Art

Primary pharmaceutical packaging means, for example vials, ampoules,syringes and carpules, are generally packaged under sterile conditionsin what are known as tubs and trays by the manufacturers before deliveryto the pharmaceutical industry for filling. These tubs mostly consist ofa support, which holds a large number of the primary packaging means andis known as the nest, and of a trough or shell into which the support isinserted. In the case of trays, a large number of the primary packagingmeans are inserted directly into the tray. The tubs and trays here areusually protectively covered by a microfibre nonwoven fabric produced bythe flash-spinning process, made of high-density polyethylene (HDPE) andknown by the trade mark Tyvek® of DuPont. Because the Tyvek® nonwoven isselectively permeable, it is also possible to use ethylene oxide orsteam to sterilize the space within the tub or within the tray after thesaid space has been protectively covered, with simultaneous creation ofa microbial barrier. Prior to sterilization, the tubs and trays aregenerally enclosed securely within one or two bags.

The pharmaceutical industry uses controlled, sterile conditions forremoval of the packaging from the sterile primary packaging means andfilling of the same. Procedures known as disinfection steps are carriedout here on transition from higher to lower cleanroom classes. These caninvolve the removal of a packaging layer, e.g. of a bag, or elsebiological decontamination inter alia by means of electron beam,hydrogen peroxide or wiping with an alcohol solution. Before the tubs ortrays are transferred into the aseptic region where the Tyvek® sealantfilm is removed and then the active pharmaceutical ingredient is chargedto the primary packaging means, there is initially also a furtherdecontamination step. This is necessary because it is not possible toensure the sterility of the external side of the tub or of the tray.

The definition of bags generally requires that—irrespective of the fillaperture—at least one of the three sides has not been sealed, welded oradhesive-bonded, i.e. that it is a lateral-seam bag or a basal-seam bag,produced from a tube or from a halved tube or a folded flat film. Incontrast to this, pouches are generally defined as having a welded seamor seal seam or adhesive bond at all three sides, because they areproduced from two or more separate film webs. The closed pouchaccordingly then has a welded bond, sealed bond or adhesive bond at allsides. For the purposes of this application, the term “bag” is employedas an umbrella term applying not only to bags but also to pouches.

A reason for the impossibility of ensuring the sterility of bagpackaging consists in the extent to which the seal seams are impermeableand durable. Various defects can arise in the seal seam not only duringsealing of bags during production but also during the final sealing ofthe bag after filling; these result from what is known as undersealingor oversealing, i.e. sealing outside of ideal parameters. In the case ofundersealing, the layers are insufficiently bonded because temperatures,pressures or sealing times are inadequate, and the resultant seal seamtherefore exhibits low adhesion. The defect is apparent in seal-seamseparation or in formation of channels and cavities.

In contrast to the above, oversealing results in small holes termedpinholes in the seal seam, caused by excessive temperatures, pressuresor sealing times; the polymer, melting in its entirety, is laterallydisplaced, and the remaining seal seam is therefore too thin, andmoreover can also suffer further thinning in the region where it adjoinsthe remainder of the film; or in extreme cases the polymer actuallysuffers thermal degradation.

There is insufficient possibility for checking of the seal seams whilethe production process is running, because the defects are notsufficiently discernible during conventional inspection of the sealseams from the film side by camera. Crystalline Tyvek® nonwovens melt inthe region of the seal seam during sealing and thus lose their whitecolour at those locations; the resultant poor contrast makes it verydifficult to discern the transparent seal seam and defects therein byoptical methods.

SUMMARY

The present invention is intended to eliminate these disadvantages ofthe prior art. In particular, a packaging is to be provided that ensuresthe sterility of the contents in a manner that is reliable and can beguaranteed, thus eliminating the previous requirement for an additionalsterilization step carried out by the pharmaceutical industry.

In another aspect, the intention is to permit improved detection of sealseam defects.

This object is achieved via packaging for the sterile packaging ofobjects for medical, pharmaceutical or cosmetic applications comprisingat least one bag made of a first and a second web, bonded to oneanother, a feature thereof being that the first web consists of aselectively permeable nonwoven fabric and that the second web consistsof a laminated film with at least three layers, where the first layer isa polymer film arranged on the external side of the bag, the secondlayer is a lamination adhesive and the third layer is a polymer filmarranged on the internal side of the bag; at least one of the layers ofthe second web comprises one or more pigments.

In one embodiment, the melting point of the polymer of the first layeris above the sealing-initiation temperature of the third layer by atleast 20° C.

For the purposes of this application, the expression “melting point ofthe polymer” means the peak minimum of the melting peak of the secondheating cycle in differential scanning calorimetry (DSC) with heatingrate 20 K/min. For the purposes of this application, the expression“sealing-initiation temperature of the polymer” means the temperature atwhich a seal seam strength of at least 4 N/15 mm, measured in accordancewith DIN EN 868-5:2009 Annex D, is achieved during the sealing of thetwo webs of the bag.

In an 8-bit greyscale image recorded in transmitted light andcontrast-standardized, the seal seam in one embodiment is depictedwithin a greyscale value range of 50-200.

For the purposes of the application, the term “contrast-standardized”means a linear expansion of the greyscale-value scale of the recordedimage to the full 0-255 range of the 8-bit scale, so that contrast ismaximized. If g_(min) and g_(max) define the minimal and maximalgreyscale values of the image, the expanded greyscale-value scale iscalculated from the following formula:

${f(g)} = {\frac{255}{g_{\max} - g_{\min}} \cdot \left( {g - g_{\min}} \right)}$

In one embodiment, the remission τ_(vis) of the seal seam, measured inaccordance with DIN 5033-1:2009-5 in remission mode with 2° observer, is10%-40%. The remission τ_(vis) can also be 12%-38%, 14%-36%, 16%-34%,18%-32%, 20%-30%, 22%-28% or 24%-26%.

In one embodiment, the remission T, measured in remission mode with 2°observer in accordance with DIN 5033-1:2009-5, of the seal seam and ofthe first web exhibit a difference of 30-75 percentage points. Thedifference can also be 35-70, 40-65, 45-60 or 50-55 percentage points.

In an 8-bit greyscale image recorded in transmitted light andcontrast-standardized, the seal seam in one embodiment exhibitsgreyscale values which are at least 30 units above, 40 units above, 50units above, 60 units above, 70 units above, 80 units above, 90 unitsabove or 100 units above the greyscale values of the region surroundingthe seal seam.

It is preferable that in the second web the first layer is a polyesterfilm or polyamide film and the third layer is a film made ofpolyethylene homo- or copolymers, of polypropylene homo- or copolymersor of polyester homo- or copolymers.

This structure of the bag achieves a plurality of advantagessimultaneously. The design of the second web as laminated film reducesthe risk of undesired permeability due to pinholes, which can ariseduring extrusion of the individual films. The lamination adhesive layerapplied between the film layers seals any pinholes that may be present,thus eliminating leakages in the film.

An external layer of polyester or of polyamide improves the edge regionsof the seal seam, in particular when heat is introduced from thepolyester side or polyamide side. To this end, the melting point of theexternal first film layer can be above the sealing-initiationtemperature of the internal third layer by at least 20° C., at least 25°C., at least 30° C., at least 35° C. or at least 40° C. The meltingpoint of the first film layer can by way of example be at least 200° C.,at least 210° C. or at least 220° C. The external layer therefore doesnot melt concomitantly during sealing; the only layer that melts is theinterior layer functioning as sealable layer. The boundary area betweenthe seal seam and the unsealed region of the nonwoven fabric is thussubstantially less stressed than, for example, when the conventionalsimple film layer made of HDPE is used and is sealed to a Tyvek®nonwoven. This results in less failure of the Tyvek® layer or nonwovenfabric layer at the seal seam. The nonwoven fabric layer can moreover befully melted throughout the seal seam; this leads to improved bonding ofthe layers, with increased seal seam strength, and also to a transparentor translucent seam, and by virtue of the laminated bond to thepolyester layer or polyamide layer it is also possible to achieveincreased puncture resistance of the film side of the bag.

Finally, the colouring of one or more of the film layers improvescontrast and thus permits fully satisfactory detection not only ofundersealing but also of oversealing. Because the seal seam istransparent or translucent, a camera can be used to study the seal intransmitted light. The seal seam is then particularly clearly visiblewhen the increased contrast is combined with a camera directed onto thewhite nonwoven-fabric side of the packaging. It is thus possible, in agreyscale analysis of the transmitted-light image, to achieve reliabledetection of every type of defect in the seal seam, and to isolate thebag. The only remaining restriction on the minimal detectable defectsize is then the resolution of the camera system.

The quantity, particle size and colour of the pigments to be used hereare to be selected according to the invention such that they optimizethe appearance of the seal seam for optical detection of the seal seamand defects therein, in transmitted light or reflected light. To thisend, adjustment of the quantity, particle size and colour of thepigments is preferably such that in a contrast-standardized 8-bitgreyscale image the seal seam is depicted in a greyscale range of50-200, 60-190, 70-180, 80-170, 90-160, 100-150 or 110-140. Thegreyscale values are preferably <200, <190, <180, <170, <160, <150. Bythis means it is possible to achieve particularly good contrast inrelation to the surrounding area of the unsealed nonwoven layer.

It is moreover in particular also possible by way of quantity andparticle size of the pigments to set a remission τ_(vis) of 10%-40%,12%-38%, 14%-36%, 16%-34%, 18%-32%, 20%-30%, 22%-28% or 24%-26%,measured in remission mode with 2° observer in accordance with DIN5033-1:2009-5 for the seal seam. With the resultant haze value of theseam, in conjunction with the increased contrast, it is possible toachieve particularly effective detection in the images of individualsealing defects. Variations in degrees of mattness in the seam indicateinhomogeneous melting or incorrect pressure applied by the sealingelements. Formation of microchannels in the seal seam can likewise bediscerned very successfully, because these are clearly distinguishablefrom the surrounding matt area.

It can also be advantageous, on top of using only the pigments toestablish the remission τ_(vis) measured in remission mode, to makeadditional use of a scattering additive which increases the proportionof back-scattered light, and thus increases the remission τ_(vis)measured in remission mode, without reducing remission to the sameextent. The quantity of light remaining for the transmitted-light imageafter passage through the seal seam is thus increased, and this in turncan lead to improved contrast. These scattering additives, which canalso themselves be coloured materials, are known in principle to theperson skilled in the art by way of example from EP 0 269 324 A2. Thescattering additive here can be used in the same layer(s) as thepigment, or can be used separately therefrom.

It is preferable that the polyester film or polyamide film of the firstlayer of the second web is free from pigments. This has the advantage ofparticularly effective detection of oversealing. Under ideal sealingconditions, no concomitant melting of the transparent or translucentpolyester or polyamide layer occurs. When, in the case of oversealing,the coloured layers of the polyethylene and/or of the laminationadhesive situated thereunder are displaced, the camera image intransmitted light reveals transparent regions on each side of a colouredregion within the otherwise white nonwoven fabric.

The selectively permeable nonwoven fabric of the first web can be amicrofibre nonwoven fabric made of high-density polyethylene (HDPE),polypropylene (PP) or polyethylene terephthalate (PET). By way ofexample, the HDPE nonwoven fabrics of the Tyvek® range from DuPont aresuitable for the purposes of the invention. It is preferable to use theuncoated products of the said range (e.g. Tyvek® 1073B). The ability ofa nonwoven fabric to form a sterilizable microbial barrier, i.e.selective permeability in respect of barrier action for microbes withsimultaneous permeability to sterilization media such as ethylene oxideor hydrogen peroxide vapours is an essential precondition for itsselection.

The polymer of the third layer of the second web can be a polyethylene,polypropylene or polyester. The polymers here can be used in the form ofhomopolymers or in the form of copolymers composed of more than 50% ofthe specified monomers. It is preferable that the polymer here isselected appropriately for the polymer of the nonwoven fabric, in orderto optimize sealability. Possibilities here are use of the same polymerclass or indeed use of the same polymer type.

The polyethylene of the third layer of the second web can be ahigh-density polyethylene (HDPE), medium-density polyethylene (MDPE),low-density polyethylene (LDPE) or linear low-density polyethylene(LLDPE), or respective copolymers of these composed of more than 50% ofthe specified monomers. Preference is given to HDPE, MDPE or LDPE. HDPEhas the advantage that the packaging can then also be sterilized withsteam, in addition to ethylene oxide or hydrogen peroxide vapours.Sterilization by radiation is possible in all variants.

The polyester film of the first layer of the second web can consist ofpolyethylene terephthalate (PET) or polybutylene terephthalate (PBT).The polyamide film of the first layer of the second web can consist ofPA 6, PA 6.6 or PA 12. Use of these materials ensures in each case thatthe bag has good puncture resistance together with good transparency.They thus contribute in two respects to the desired aim of packagingwith sterility that can be guaranteed. Firstly, across the entiresurface of the packaging they prevent undesired permeability due todefects or film failure under mechanical stress, and secondly theycontribute to improvement of defect detection in the seal seams of thepackaging.

The lamination adhesive of the second layer of the second web ispreferably a polyurethane-based (PUR) adhesive. In particular, thisadhesive is preferably a non-reactive PUR hotmelt adhesive. Pinholes areavoided throughout the entire film firstly simply through the laminationof the two films. Any pinholes that may be present in the individualfilms are additionally particularly effectively sealed by the PUR-basedlamination adhesive. The quantity applied of the lamination adhesive canbe 0.5-15 g/m² or 1.0-12 g/m² or 1.2-10 g/m² or 1.4-8.0 g/m² or 1.6-6.0g/m² or 1.8-5.0 g/m² or 2.0-4.0 g/m².

In embodiments of the invention, the bonding of the webs of the bag, toform the bag, is achieved via sealing or adhesive bonding, and closureof the filled bag is achieved by means of a seal seam. It is preferablethat seal seams are used not only to form the bag but also to close thefilled bag. This permits checking of the integrity of the seams with theaid of a camera in transmitted light on all sides of the bag. The sealseam is moreover more robust than an adhesive bond.

The seal seam strength of the seal seams of the bag is most preferablyat least 20 N/15 mm, at least 22 N/15 mm, at least 25 N/15 mm or atleast 30 N/15 mm measured in accordance with DIN EN 868-5:2009 Annex D.

The puncture resistance measured in accordance with DIN EN 14477:2004 attest velocity 100 mm/min and with 0.8 mm tip diameter of the first webof the bag is preferably at least 10 N, at least 11 N, at least 12 N, atleast 13 N or at least 14 N.

The puncture resistance of the second web of the bag, measured inaccordance with DIN EN 14477:2004 at test velocity 100 mm/min and with0.8 mm tip diameter, is preferably at least 4.5 N, at least 5.0 N, atleast 5.5 N, at least 6.0 N or at least 6.5 N.

In one embodiment of the invention, arranged within the bag, there is atub in the form of a trough or shell to receive the objects. Arranged inthe tub there is preferably a support, known as a nest. The nest hasoptionally been securely bonded to the tub, preferably in a one-piecestructure. In another embodiment of the invention, there is, arrangedwithin the bag, a tray to receive the objects. A large number of primarypharmaceutical packaging means, for example vials, carpules or syringes,are thus frequently received, and securely arranged, either in the nestor in the tray.

The tub or tray has most preferably been protectively covered with aselectively permeable nonwoven fabric via sealing or adhesive bonding.This can be the same as the nonwoven fabric used to form the bag.However, it is also possible to use a different nonwoven fabric whichhas the same properties in respect of selective permeability but by wayof example consists of a material better suited to sealing to thematerial of the tub or tray.

In another embodiment of the invention, the bag has been surrounded byone or more further bags. It is preferable here that the bags have thesame structure as the first bag and merely have appropriately largerdimensions. The entire packaging thus created is suitable, in the stepsof a packaging-removal procedure in a progressively cleaner environment,for avoiding contamination while bringing the contents to the usagelocation or filling location in the pharmaceutical industry. In thoselocations, in the case of packaging made of a sealed tub or traysurrounded by two bags, the first bag is accordingly opened in a class Ccleanroom environment, the second bag is opened in class B, and finallythe tub or tray is opened in class A.

A process of the invention for the sterile packaging of objects formedical, pharmaceutical or cosmetic applications features use of apackaging described above.

The invention moreover provides a process for seal seam monitoring for abag made of a first web made of a selectively permeable nonwoven fabricand of, bonded thereto, a second web consisting of a laminated film withat least three layers, where the first layer is a polymer film arrangedon the external side of the bag, the second layer is a laminationadhesive and the third layer is a polymer film arranged on the internalside of the bag, the melting point of the polymer of the first layerbeing above the sealing-initiation temperature of the third layer by atleast 20° C., and where at least one of the layers of the second webcomprises one or more pigments, comprising the steps of: provision ofthe webs of the bag in a manner such that in an 8-bit greyscale imagerecorded in transmitted light and contrast-standardized, the seal seamis depicted within a greyscale value range of 50-200, and the remissionτ_(vis) of the seal seam, measured in accordance with DIN 5033-1:2009-5in remission mode with 2° observer, is 10%-40%; imaging of the seal seamby a camera system in transmitted light to generate an 8-bit greyscaleimage, and contrast-standardization of the same; and evaluation of thecontrast-standardized 8-bit greyscale image in respect ofinhomogeneities in the greyscale values of the seal seam.

The packaging system of the invention is therefore successful inestablishing optical monitoring—simply with the naked eye, or else inautomated form with the aid of a camera inspection system—which permitsreliable recognition of sealing defects not only in the case ofoversealing but also in the case of undersealing. It is thus possible toisolate all bags with defects in the seal seam. The possibleoptimization of the seal seam moreover provides not only transparency ortranslucency thereof, which improves detection, but also improves sealseam strength.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exemplary embodiment of a bag.

FIG. 2 shows the layer structure of a bag of Example 1.

FIG. 3 shows the layer structure of a bag of Example 2.

FIG. 4 shows an evaluation profile of a poor seal seam of Example 1.

FIG. 5 shows an evaluation profile of a good seal seam of Example 1.

DETAILED DESCRIPTION

FIG. 1 illustrates an exemplary embodiment of a package or bag (10) ofthe present application that has a first web (1) and a second web (2)for sterile objects for medical, pharmaceutical or cosmetic applications(12). The sterile objects (12) can be, for example, sterile primarypharmaceutical packaging means, including vials, ampoules, syringes orcarpules. In the illustrated embodiment, arranged within the bag (10),there is a tray (14) to receive the objects (12). A large number ofprimary pharmaceutical packaging means (12), for example vials, carpulesor syringes, are thus frequently received, and securely arranged, eitherin the tray (14).

FIGS. 2 and 3 illustrate a seal region of the first web (1) and thesecond web (2) to one another. The depiction of the layer thicknesses inFIGS. 2 and 3 is not to scale, but is merely a rough approximation.

The invention is described below on the basis of Examples. These servemerely to illustrate examples of embodiments of the invention, and arenot to be understood as restrictive.

Example 1

Bags (10) were produced from a first web (1) and a second web (2). Thefirst web (1) consisted of Tyvek® 1073 B uncoated nonwoven HDPE fabric(3) from DuPont with thickness about 180 μm. The second web (2)consisted of, arranged on the external side, a first layer (4) made of aPET film of thickness 12 μm and, bonded thereto by means of the secondlayer (5) of 2.5 g/m² of a PUR-based hotmelt lamination adhesive, athird layer (6) made of LDPE with thickness 50 μm. The third layer (6)made of LDPE had been coloured blue with a pigment, while the other twolayers were transparent and colourless. The layer structure is depictedin FIG. 2.

The bag (10) was formed by using an AccuSeal 6300-25-X impulse sealer at180-190° C. with pressure 5.5-6 bar and sealing time 3-4 s to applythree seal seams of width 3 mm, 6 mm or 10 mm. Heat was introduced fromone side: the polyester film side. A further seal seam was provided forthe closure of the filled bag (10), thus then giving a packaging sealedat all sides. In the seal seam achieved during the sealing procedure,the molten nonwoven fabric layer was transparent, and the blue colour ofthe LDPE layer was clearly discernible. The seal seams were subjected toinspection by camera; cameras recorded images of the seal seams intransmitted light, and the images were then analysed. To this end,evaluation software was used in the standardized greyscale depictions toplot profiles at right angles across the seal seams. Each of FIGS. 4 and5 shows by way of example an individual sectional profile through theseal seam. The greyscale value across the studied section is plottedhere. For assessment at the seal seam in the production process, it willbe self-evident that the software evaluates the depiction of the entireseal seam.

FIG. 4 depicts a defective seam. The transparent areas at the seam edgesare clearly visible, revealed by pale peaks. Incorrect temperatureand/or incorrect sealing jaw pressure here has caused the coloured LDPEsealable layer to disappear completely as a result of melting, so thatthe edges are then formed only by the transparent colourless PET film;these then appear in the white region of greyscale values in transmittedlight.

In contrast to the above, FIG. 5 shows a fully satisfactory seal seam,the curve profile of which is very close to the ideal rectangular curve.

Example 2

Bags were produced from a first web (1) and a second web (2). The firstweb (1) consisted of Tyvek® 1073 B uncoated nonwoven HDPE fabric (3)from DuPont with thickness about 180 The second web (2) consisted of,arranged on the external side, a first layer (4) made of a PET film ofthickness 12 μm and, bonded thereto by means of the second layer (5) of2.5 g/m² of a PUR-based hotmelt lamination adhesive, a third layer (7)made of HDPE with thickness 50 μm. The third layer (7) made of HDPE hadbeen coloured blue with a pigment, while the other two layers weretransparent and colourless. The layer structure is depicted in FIG. 3.

The bag (10) was formed by using an AccuSeal 6300-25-X impulse sealer at180-185° C. with pressure 5.7-6.2 bar and sealing time 3.5-4.5 s toapply three seal seams of width 3 mm, 6 mm or 10 mm. Heat was introducedfrom one side: the polyester film side. A further seal seam was providedfor the closure of the filled bag (10), thus then giving a packagingsealed at all sides. In the seal seam achieved during the sealingprocedure, the molten nonwoven fabric layer was transparent, and theblue colour of the HDPE layer was clearly discernible. As in Example 1,the seal seams were subjected to inspection by camera; cameras recordedimages of the seal seams in transmitted light, and the images were thenanalysed. Here again, the seal seams were extremely easy to detect, anddefects could be discerned in a fully satisfactory manner.

Test Methods

Seal seam strength was determined in accordance with DIN EN868-5:2009-09. Five strips of width 15 mm and length 5 cm were cut outfrom the packaging material to be tested. The specimen here was cut outat right angles to the seal seam. The strips were moreover cut out atvarious positions along the seam to be tested, but with a minimumdistance of 2 cm from the external edge. A mark was then made parallelto the seal seam on each strip at a distance of 3 cm from the seal seamtowards the interior of the packaging. These marks served for clampingpurposes. The entirety of the lower end of the strip was clamped intothe lower clamp. The seal seam was parallel to the edge of the upperclamp. The other end of the test sample was clamped into the upper clampin a manner such that the added markings were directly in contact withthe lower edge of the upper clamp while the test sample had not yet beensubjected to any stress. The test was then carried out with unsupportedtab with test velocity 200 mm/min until failure of the test sample wasobserved.

Puncture resistance was determined in accordance with DIN EN 14477:2004.All samples were stored for at least 48 h at 23° C./50% rh. These werethen tested under the same temperature/humidity conditions. The testincluded ten individual measurements per sample. The films were clampedinto the tester with the internal side facing upwards. The test probe,diameter 0.8 mm, was forced through the film at a test velocity of 100mm/min until failure occurred.

Remission τ_(vis), measured in remission mode with 2° observer inaccordance with DIN 5033-1:2009-5, was measured with a Lambda 900spectrometer from Perkin Elmer, which was used in remission mode andrecorded in the range from 360 nm to 780 nm, equipped with a 60 mmintegration sphere and with a sample holder at 11°. A standard D65illuminant was used. Evaluation with 2° observer was carried out inaccordance with DIN 5033-1:2009-5.

Seal Seam Strength

Sample strips of seal seams were taken as described above for seal seamstrength measurement from all sides of the bags (10) formed. Themeasured values given in TABLE 1 are in each case the smallest valuesmeasured.

The resultant sample strips were tested as described above. A bag (10)in the usual embodiment using a web of DuPont Tyvek® 1073B (130-180 μm)and with a web of HDPE (80 μm) was taken as Comparative Example. TABLE 1lists the test results.

TABLE 1 Sample Seal seam strength [N/15 mm] Example 1 30 N Example 2 27N Comparative Example 12.5 N

For the bags (10) of the invention with a laminate web, the measuredvalues reveal on average a seal seam strength that is about two to threetimes greater than for the familiar variant with Tyvek® 1073B and HDPE.

Puncture Resistance

Samples of the two webs (1, 2) were taken for the bags (10) of Examples1 and 2 and of Comparative Examples 1 and 2, and tested in accordancewith the method described above. Comparative Example 1 here correspondsto the bag (10) with one web (1) of DuPont Tyvek® 1073B and one web (2)of HDPE, and Comparative Example 2 here corresponds to a bag (10) withone web (1) made of a polypropylene microfibre nonwoven (88-98 g/m²) andone web (2) of a laminate made of a polyester film (12 μm) and apolypropylene film (38 μm). TABLE 2 collates the results.

TABLE 2 Puncture resistance [N] Sample Web 1 Web 2 Example 1 16.9 N 7.3N Example 2 16.9 N 7.2 N Comparative Example 1 16.9 N 3.5 N ComparativeExample 2 16.0 N 6.8 N

The measured values reveal not only that with the layer structure of theinvention the bag (10) permits improved detection of seal seam defectsbut also at the same time that the robustness of the packaging isfurther increased.

Remission τ_(Vis)

The respective seal seams and the two webs (1) and (2) of bags (10) ofExamples 1 and 2 were tested in remission mode as described above. Thesample of the webs (1, 2) here were taken at a lateral distance of 10 mmfrom the tested seal seam area. The results are shown in TABLE 3 below.

TABLE 3 Remission τ_(VIS) [%] EXAMPLE 1 Seal seam 18.0 Web (1) 77.1 Web(2) 22.1 EXAMPLE 2 Seal seam 18.0 Web (1) 77.5 Web (2) 22.0

Example 3

A bag (10) structure as in Example 1 was used for packaging, on anautomated packing line, of vials (12) stored in a nest in a trough (14)protectively covered with a layer (16) of Tyvek® 1073 B. Theprotectively covered trough (14) here was placed into two enclosing bags(10, 10′) as packaging as shown in FIG. 1. Sealing of the bags (10, 10′)here was monitored by the installed camera-inspection system intransmitted light, viewing the Tyvek® side. Here again, the seal seamswere extremely easy to detect, and defects could be discerned in a fullysatisfactory manner.

What is claimed is:
 1. Packaging for the sterile packaging of objectsfor medical, pharmaceutical or cosmetic applications, comprising: afirst web; a second web; and a seal seam bonding the first and secondwebs to one another to define a portion of a bag, the bag having aninternal side and an external side, the first web consists of aselectively permeable nonwoven fabric, the second web consists of alaminated film with a first layer, a second layer, and a third layer,the first layer is a polymer film arranged on the external side, thesecond layer is a lamination adhesive, and the third layer is anotherpolymer film arranged on the internal side, the first layer having amelting point that is above a sealing-initiation temperature of thethird layer by at least 20° C., at least one of the first, second, andthird layers comprising a pigment, wherein the seal seam, in an 8-bitgreyscale image recorded in transmitted light and contrast-standardized,is within a greyscale value range of 50-200, and wherein the seal seamhas a remission τ_(vis), measured in accordance with DIN 5033-1:2009-5in remission mode with 2° observer, that is 10%-40%.
 2. The packagingaccording to claim 1, wherein the polymer film of the first layer is apolyester film or polyamide film, and wherein the polymer film of thethird layer is made of a material selected from a group consisting ofpolyethylene homopolymers, polyethylene copolymers, polypropylenehomopolymers, polypropylene copolymers, polyester homopolymers, andpolyester copolymers.
 3. The packaging according to claim 1, wherein theselectively permeable nonwoven fabric is a microfibre nonwoven fabricmade of a material selected from a group consisting of high-densitypolyethylene (HDPE), polypropylene (PP), and polyethylene terephthalate(PET).
 4. The packaging according to claim 1, wherein the polymer filmof the third layer is made of a material selected from a groupconsisting of high-density polyethylene (HDPE), medium-densitypolyethylene (MDPE), low-density polyethylene (LDPE), and linearlow-density polyethylene (LLDPE).
 5. The packaging according to claim 1,wherein the polymer film of the first layer is a polyester film or apolyamide film that is free from the pigment.
 6. The packaging accordingto claim 1, the polymer film of the first layer is a polyethyleneterephthalate (PET) or polybutylene terephthalate (PBT).
 7. Thepackaging according to claim 1, wherein the seal seam exhibits greyscalevalues which are at least 30 units above greyscale values of a regionsurrounding the seal seam.
 8. The packaging according to claim 1,wherein the portion of the bag defined by the seal seam comprises aclosure of a filled bag.
 9. The packaging of claim 8, further comprisinga sealing or adhesive bonding connecting the first and second webs toone another to define remaining portions of the bag.
 10. The packagingaccording to claim 1, wherein the seal seam exhibits a homogenouscolour.
 11. The packaging according to claim 1, wherein the seal seamhas a strength that is at least 20 N/15 mm measured in accordance withDIN EN 868-5:2009 Annex D.
 12. The packaging according to claim 1,wherein the first web has a puncture resistance measured in accordancewith DIN EN 14477:2004 at test velocity 100 mm/min and with 0.8 mm tipdiameter that is at least 10 N and/or wherein the second web has apuncture resistance measured in accordance with DIN EN 14477:2004 attest velocity 100 mm/min and with 0.8 mm tip diameter that is at least4.5 N.
 13. The packaging according to claim 1, further comprisinganother bag surrounding the bag.
 14. The packaging according to claim 1,wherein the remission τ_(vis) of the seal seam exhibits a difference of30-75 percentage points to a remission τ_(vis) of the first web measuredin accordance with DIN 5033-1:2009-5 in remission mode with 2° observer.15. The packaging according to claim 1, further comprising a tub or trayarranged in the bag.
 16. The packaging according to claim 15, furthercomprising one or more objects for medical, pharmaceutical or cosmeticapplications in the tub or tray.
 17. The packaging according to claim15, wherein the tub or tray comprises a protective covering of anotherselectively permeable nonwoven fabric sealed or adhesive bonded thereto.